BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SNARE

    MDR report key: 3840831 · Received May 30, 2014

    Report

    Report Number
    3005099803-2014-02042
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    March 24, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K992477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE INVESTIGATION FINDINGS OF FLARE DETACHED. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FLARE WAS DETACHED, ALSO THE WIRE AND CATHETER NEAR THE HANDLE WERE KINKED. THE DEVICE HAS EVIDENCE OF THE FLARE MANUFACTURING PROCESS. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE FLARE DETACHMENT. THE COMPLAINT THAT LOOP FAILED TO EXTEND WAS CONFIRMED; THE DETACHED FLARE PREVENTED ACTUATION OF THE DEVICE. MANIPULATION OF THE DEVICE DURING THE PROCEDURE LIKELY PRODUCED THE KINKS FOUND IN THE WIRE AND THE CATHETER. THE FLARE DETACHMENT CAN BE CAUSED WHEN EXTRA FORCE IS APPLIED IN ORDER TO EXTEND THE SNARE. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS REPORTED EVENT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED BATCH

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2014-02042 PERTAINS TO THE FIRST ROTATABLE SMALL OVAL SNARE AND MANUFACTURER REPORT #3005099803-2014-02041 PERTAINS TO THE SECOND ROTATABLE SMALL OVAL SNARE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ROTATABLE SMALL OVAL SNARES WERE USED IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARES FAILED TO EXTEND. THE PROCEDURE WAS COMPLETED WITH A THIRD ROTATABLE SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: FLARE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318481 ROTATABLE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561821 16648473

    Patients

    Seq Age Sex Outcome Treatment
    1